About Ferrlecit
What is Ferrlecit?
Ferrlecit is an intravenous (IV) iron replacement product for the treatement of
iron deficiency anemia in patients 6 years and older with chronic kidney disease
receiving chronic hemodialysis (HD) and supplemental epoetin therapy.
Turn to Ferrlecit for...
Experience
- Established efficacy for both initial
repletion and IV iron therapy after repletion treatment1,2
- Established efficacy in ESA-resistant patients3
Confidence
- Wealth of clinical data, including 10+ years of clinical experience in the US
- Established safety—even in pediatric settings
- Flexible administration
with no test dose required4
Support
Learn about
Ferrlecit dosing and administration
Important Safety Information for Ferrlecit
Serious hypersensitivity reactions, including anaphylactic-type reactions, some
of which have been life-threatening and fatal, have been reported in patients receiving
Ferrlecit (sodium ferric gluconate) in post marketing experience. Patients may present
with shock, clinically significant hypotension, loss of consciousness, or collapse.
Monitor patients for signs and symptoms of hypersensitivity during and after Ferrlecit
administration for at least 30 minutes and until clinically stable following completion
of the infusion. Only administer Ferrlecit when personnel and therapies are immediately
available for the treatment of anaphylaxis and other hypersensitivity reactions.
- Ferrlecit is contraindicated in patients with known hypersensitivity to Ferrlecit.
- Ferrlecit may cause clinically significant hypotension. Administration of
Ferrlecit may augment hypotension caused by dialysis and usually resolves within
one to two hours. Monitor patients for sign and symptoms of hypotension during and
following administration.
- Do not administer to patients with evidence of iron overload.
- Ferrlecit contains benzyl alcohol as a preservative. Benzyl alcohol has been
associated with serious adverse events and death in pediatric patients. Caution
should be exercised when Ferrlecit is administered to a pregnant or nursing woman.
- The most commonly reported adverse reactions (≥10%):
- In adult patients were nausea, vomiting and/or diarrhea, injection site reaction,
hypotension, cramps, hypertension, dizziness, dyspnea, chest pain, leg cramps and
pain.
- In patients 6 to 15 years of age the most common adverse reactions (≥10%)
were hypotension, headache, hypertension, tachycardia and vomiting.
For more information on Ferrlecit, please see full Prescribing Information.
References:
1. Nissenson AR, Lindsay RM, Swan S, Seligman P, Strobos J. Sodium
ferric gluconate complex in sucrose is safe and effective in hemodialysis patients:
North American Clinical Trial. Am J Kidney Dis. 1999;33:471-482.
2. Bolaños L, Castro P, Falcón TG, Mouzo R, Varela JM. Continuous
intravenous sodium ferric gluconate improves efficacy in the maintenance phase of
EPOrHu administration in hemodialysis patients. Am J Nephrol. 2002;22:67-72.
3. Ferrlecit® Prescribing Information, sanofi-aventis
U.S. LLC.
4. Michael B, Coyne DW, Fishbane S, et al; for the Ferrlecit®
Publication Committee. Sodium ferric gluconate complex in hemodialysis patients:
adverse reactions compared to placebo and iron dextran. Kidney Int. 2002;61:1830-1839.